Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Starting soon Observational

Microbiome and Polycystic Ovaries

NCT04836910 · tracked via the Priya Life Science Israel tracker
Phase
Observational
Started
2025-09-01
Last updated
2024-11-14

Condition(s) studied

Polycystic Ovary SyndromeMicrobial Colonization

Investigational drug(s) / intervention(s)

Dietary recommendationsOral contraceptive pillsMetformin →

Dietary recommendations: Fruit, vegetables, legumes (e.g. lentils and beans), nuts and whole grains (e.g. unprocessed maize, millet, oats, wheat and brown rice). At least 400 g (i.e. five portions) of fruit and vegetables per day excluding potatoes, sweet potatoes, cassava and other starchy roots. Less than 10% of total energy intake from free sugars Less than 30% of total energy intake from fats. Unsaturated fats (found in fish, avocado and nuts, and in sunflower, soybean, canola and olive oils) are preferable to saturated fats. Less than 5 g of salt (equivalent to about one teaspoon) per day.

Oral contraceptive pills: Hormonal treatment

Metformin: Insulin resistance treatment

Study summary

Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS .

Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
42 Years
Healthy volunteers
No
Inclusion Criteria: Study group: Untreated women diagnosed with PCOS that are planned for intervention. Control group: Women without PCOS visiting the gynecologic outpatient's clinics. Exclusion Criteria: 1. Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor). 2. Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics/ probiotics, hormonal, vaginal or laxative medicine (in the previous week). 4\. Vaginitis/ Pelvic Inflammatory Disease (PID)

Primary outcome measure(s)

  • Vaginal and gut microbiota composition before and after intervention recommended and in comparison to women without PCOS. — Through study completion, an estimated period of 1 year
    Evaluated by PCR ( ng/microl)

Trial sites (1)

FacilityCityRegionStatus
Sheba Medical Center Ramat Gan Israel
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04836910 on ClinicalTrials.gov ↗ ← All trials in Israel